Heart Health

This news channel includes content on cardiovascular disease prevention, cardiac risk stratification, diagnosis, screening programs, and management of major risk factors that include diabetes, hypertension, diet, life style, cholesterol, obesity, ethnicity and socio-economic disparities.
 

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A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]

Most recalled cardiovascular devices gained FDA approval with little to no clinical evidence

Why are so many cardiovascular devices involved in Class I recalls? One possible reason could be the large number of devices hitting the market without undergoing much premarket clinical testing. 

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FTC sues drug middlemen over insulin prices, puts others on notice

The FTC alleges that pharmacy benefit managers have set up a system where they get rich, while patients are forced to pay rising insulin costs. The agency also called out drug manufacturers such as Eli Lilly, Sanofi and Novo Nordisk, saying their own actions have raised serious concerns.

Abbott’s FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system

Safety update: Sensor issue with Abbott CGMs ruled a Class I recall

The sensors of certain FreeStyle Libre 3 devices are producing inaccurate glucose readings and should not be used. Two patient injuries have been reported. Abbott first reported the problem in July. 

Brittany Nicole Weber, MD, PhD, Brigham and Women's Hospital, explains the growing role of cardio-rheumatology clinics.

The growing role of cardio-rheumatology clinics

Cardio-rheumatology clinics use a heart team-like approach to enhance care for patients with chronic conditions such as lupus, psoriasis and rheumatoid arthritis. "It's not just about cardiology," the director of one clinic explains. "We work closely with rheumatologists, dermatologists and even primary care physicians to provide comprehensive care."

Insulet Corporation, a Massachusetts-based medical device company focused on diabetes technology, announced that its Omnipod 5 Automated Insulin Delivery System is now cleared by the U.S. Food and Drug Administration (FDA) to manage type 2 diabetes (T2D).

FDA clears first automated insulin pump for type 2 diabetes

Insulet's Omnipod 5 Automated Insulin Delivery System was already cleared to help patients manage type 1 diabetes. 

Medicare coverage for weight loss drug semaglutide could cost up to $145B per year

Medications that target obesity are not typically covered by Medicare. When the FDA approved semaglutide as a way to treat certain cardiovascular risks, however, CMS said Medicare coverage was on the table. 

Tandem Diabetes Care is recalling a recent update of the mobile app for its t:slim X2 insulin pump due to repeated software issues that may cause the pump to shut down unexpectedly. The FDA has said this is a Class I recall.

Patient risks persist for insulin pump caught in Class I recall

A software update for the pump's mobile app was expected to fix ongoing battery issues, but the problem remains. 

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Medtronic and Abbott join forces to develop new diabetes tech

Medtronic and Abbott are often seen as rivals in a competitive marketplace, but the two companies are collaborating with a simple goal in mind: improving patient access to high-quality CGM devices. 

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Around the web

Cardiovascular Business
FDA says years-long tirzepatide shortage is resolved, will give limited leeway to compounders

The tirzepatide shortage that first began in 2022 has been resolved. Drug companies distributing compounded versions of the popular drug now have two to three more months to distribute their remaining supply.

AI in Healthcare
From Capitol Hill to a hospital near you? 5 federal recommendations for healthcare AI policy

The 24 members of the House Task Force on AI—12 reps from each party—have posted a 253-page report detailing their bipartisan vision for encouraging innovation while minimizing risks. 

Cardiovascular Business
Merck spends up to $2B to license new weight loss drug with potential heart benefits

Merck sent Hansoh Pharma, a Chinese biopharmaceutical company, an upfront payment of $112 million to license a new investigational GLP-1 receptor agonist. There could be many more payments to come if certain milestones are met.